CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Cx50 3.0 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK123754
510k NumberK123754
Device Name:CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover,  MA  01810
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-12-06
Decision Date2012-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838067851 K123754 000
00884838061439 K123754 000
00884838061514 K123754 000
00884838061521 K123754 000
00884838061538 K123754 000
00884838061569 K123754 000
00884838061583 K123754 000
00884838061620 K123754 000
00884838061637 K123754 000
00884838067806 K123754 000
00884838067813 K123754 000
00884838025295 K123754 000

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